Job Details
Title: Director of GCP, Quality Assurance contract
Status: 12-month contract
Location: Hybrid South San Francisco 1-2 days a week onsite.
Hourly rate: $100-$115 per hour depending on experience
This is a hands-on position responsible for all assigned activities that ensure clinical trials adhered to applicable GCP regulations.
Other duties:
- Support managing a risk-based clinical Quality Management System (QMS) for GCP QA in compliance with applicable regulatory requirements (US and OUS), and company policies.
- Author and review Standard Operating Procedures through gap analysis.
- Continue to foster Plaints culture of continuous improvement with emphasis on efficiency and effectiveness.
- Achieve assigned deliverables of the Clinical QA function.
- Conduct or provide support of GCP, GCLP, GLP, and GVP audits of clinical investigator sites, Contract Research Organizations (CROs), contract clinical laboratories, and processes/systems to determine compliance status.
Required Skillsets:
- Bachelor s degree required, advanced degree in a scientific field preferred. Quality assurance professional certification is a plus.
- At least 10 years of experience in Clinical Quality Assurance.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) and proposed (R3) for Good Clinical Practice. Experience with all phases of clinical trials.
- Knowledge and practical application of ICH E8 (R1)
- In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines.
All onsite employees and contractors to be fully vaccinated prior to their first day.